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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

TREN

Last updated

25.09.2026 12:48

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Successful

Device

3655407

Actor

47925

Certificate

3410

Active filter:Manufacturer SRN:US-MF-000010288

1000+ device results listed.

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Aspartate Aminotransferase Reagent

Aspartate Aminotransferase Reagent

IVD generalIVDDOn the marketProfessional testingReagent
Manufacturer
Beckman Coulter Inc.
Manufacturer SRN
US-MF-000010288
UDI-DI
D-467845RU
Basic UDI-DI
B-467845RU
Reference
467845
EMDN
W01010110
EMDN description
ASPARTATE AMINO-TRANSFERASE
First on market country
Ireland
Authorised representative
Beckman Coulter Ireland Inc.
Last updated
11.07.2026 19:53
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Creatine Kinase Reagent (N-Acetyl-L-cysteine) (CK- 2 x 200)

Creatine Kinase Reagent (N-Acetyl-L-cysteine) (CK- 2 x 200)

IVD generalIVDDOn the marketProfessional testingReagent
Manufacturer
Beckman Coulter Inc.
Manufacturer SRN
US-MF-000010288
UDI-DI
D-467830RF
Basic UDI-DI
B-467830RF
Reference
467830
EMDN
W01010113
EMDN description
CREATINE KINASE - TOTAL
First on market country
Ireland
Authorised representative
Beckman Coulter Ireland Inc.
Last updated
11.07.2026 19:53
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
SYNCHRON Systems Ammonia/Alcohol Control Level 3

SYNCHRON Systems Ammonia/Alcohol Control Level 3

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent
Manufacturer
Beckman Coulter Inc.
Manufacturer SRN
US-MF-000010288
UDI-DI
D-465996S4
Basic UDI-DI
B-465996S4
Reference
465996
EMDN
W0103010599
EMDN description
HAEMATOLOGY CONTROLS - OTHER
First on market country
Ireland
Authorised representative
Beckman Coulter Ireland Inc.
Last updated
11.07.2026 19:52
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
SYNCHRON Systems Ammonia/Alcohol Control Level 2

SYNCHRON Systems Ammonia/Alcohol Control Level 2

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent
Manufacturer
Beckman Coulter Inc.
Manufacturer SRN
US-MF-000010288
UDI-DI
D-465993RW
Basic UDI-DI
B-465993RW
Reference
465993
EMDN
W0103010599
EMDN description
HAEMATOLOGY CONTROLS - OTHER
First on market country
Ireland
Authorised representative
Beckman Coulter Ireland Inc.
Last updated
11.07.2026 19:52
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
SYNCHRON Systems Ammonia/Alcohol Control Level 1

SYNCHRON Systems Ammonia/Alcohol Control Level 1

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent
Manufacturer
Beckman Coulter Inc.
Manufacturer SRN
US-MF-000010288
UDI-DI
D-465990RQ
Basic UDI-DI
B-465990RQ
Reference
465990
EMDN
W0103010599
EMDN description
HAEMATOLOGY CONTROLS - OTHER
First on market country
Ireland
Authorised representative
Beckman Coulter Ireland Inc.
Last updated
11.07.2026 19:52
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Vigil™ Lipid Control Level 4

Vigil™ Lipid Control Level 4

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent
Manufacturer
Beckman Coulter Inc.
Manufacturer SRN
US-MF-000010288
UDI-DI
D-465982RR
Basic UDI-DI
B-465982RR
Reference
465982
EMDN
W0102152006
EMDN description
ANAEMIA RELATED/VITAMIN CONTROLS
First on market country
Ireland
Authorised representative
Beckman Coulter Ireland Inc.
Last updated
11.07.2026 19:52
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Vigil™ Lipid Control Level 3

Vigil™ Lipid Control Level 3

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent
Manufacturer
Beckman Coulter Inc.
Manufacturer SRN
US-MF-000010288
UDI-DI
D-465981RP
Basic UDI-DI
B-465981RP
Reference
465981
EMDN
W0102152006
EMDN description
ANAEMIA RELATED/VITAMIN CONTROLS
First on market country
Ireland
Authorised representative
Beckman Coulter Ireland Inc.
Last updated
11.07.2026 19:52
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Vigil™ Lipid Control Level 2

Vigil™ Lipid Control Level 2

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent
Manufacturer
Beckman Coulter Inc.
Manufacturer SRN
US-MF-000010288
UDI-DI
D-465980RM
Basic UDI-DI
B-465980RM
Reference
465980
EMDN
W0102152006
EMDN description
ANAEMIA RELATED/VITAMIN CONTROLS
First on market country
Ireland
Authorised representative
Beckman Coulter Ireland Inc.
Last updated
11.07.2026 19:52
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
SYNCHRON Systems Total Iron Binding Capacity (IBCT) Column Kit

SYNCHRON Systems Total Iron Binding Capacity (IBCT) Column Kit

IVD generalIVDDOn the marketProfessional testingReagent
Manufacturer
Beckman Coulter Inc.
Manufacturer SRN
US-MF-000010288
UDI-DI
D-465976RW
Basic UDI-DI
B-465976RW
Reference
465976
EMDN
W01010217
EMDN description
IRON BINDING CAPACITY - TOTAL (CC)
First on market country
Ireland
Authorised representative
Beckman Coulter Ireland Inc.
Last updated
11.07.2026 19:52
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Total Iron Binding Capacity Reagent (IBCT 2 x 100)

Total Iron Binding Capacity Reagent (IBCT 2 x 100)

IVD generalIVDDOn the marketProfessional testingReagent
Manufacturer
Beckman Coulter Inc.
Manufacturer SRN
US-MF-000010288
UDI-DI
D-465971RL
Basic UDI-DI
B-465971RL
Reference
465971
EMDN
W01010217
EMDN description
IRON BINDING CAPACITY - TOTAL (CC)
First on market country
Ireland
Authorised representative
Beckman Coulter Ireland Inc.
Last updated
11.07.2026 19:52
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Total Iron Binding Capacity Reagent (IBCT 2 x 100)

Total Iron Binding Capacity Reagent (IBCT 2 x 100)

IVD generalIVDDOn the marketProfessional testingReagent
Manufacturer
Beckman Coulter Inc.
Manufacturer SRN
US-MF-000010288
UDI-DI
D-465970RJ
Basic UDI-DI
B-465970RJ
Reference
465970
EMDN
W01010217
EMDN description
IRON BINDING CAPACITY - TOTAL (CC)
First on market country
Ireland
Authorised representative
Beckman Coulter Ireland Inc.
Last updated
11.07.2026 19:52
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
SYNCHRON Systems 125 ng/mL THC Urine Control

SYNCHRON Systems 125 ng/mL THC Urine Control

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent
Manufacturer
Beckman Coulter Inc.
Manufacturer SRN
US-MF-000010288
UDI-DI
D-465939RQ
Basic UDI-DI
B-465939RQ
Reference
465939
EMDN
W0102152009
EMDN description
CONTROLS FOR NARCOTICS / TOXICOLOGY
First on market country
Ireland
Authorised representative
Beckman Coulter Ireland Inc.
Last updated
11.07.2026 19:52
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
SYNCHRON Systems Bilirubin Calibrator

SYNCHRON Systems Bilirubin Calibrator

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent
Manufacturer
Beckman Coulter Inc.
Manufacturer SRN
US-MF-000010288
UDI-DI
D-465915RA
Basic UDI-DI
B-465915RA
Reference
465915
EMDN
W0101050302
EMDN description
CALIBRATORS SINGLE COMPONENT (CC)
First on market country
Ireland
Authorised representative
Beckman Coulter Ireland Inc.
Last updated
11.07.2026 19:52
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
SYNCHRON Systems 20 ng/mL THC Urine Control

SYNCHRON Systems 20 ng/mL THC Urine Control

IVD generalIVDDOn the marketHuman tissuesProfessional testingReagent
Manufacturer
Beckman Coulter Inc.
Manufacturer SRN
US-MF-000010288
UDI-DI
D-465914R8
Basic UDI-DI
B-465914R8
Reference
465914
EMDN
W0102152009
EMDN description
CONTROLS FOR NARCOTICS / TOXICOLOGY
First on market country
Ireland
Authorised representative
Beckman Coulter Ireland Inc.
Last updated
11.07.2026 19:52
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
SYNCHRON Systems 75 ng/mL THC Urine Control

SYNCHRON Systems 75 ng/mL THC Urine Control

IVD generalIVDDOn the marketProfessional testingReagent
Manufacturer
Beckman Coulter Inc.
Manufacturer SRN
US-MF-000010288
UDI-DI
D-465912R4
Basic UDI-DI
B-465912R4
Reference
465912
EMDN
W0102152099
EMDN description
CONTROLS- IMMUNOCHEMISTRY - OTHER
First on market country
Ireland
Authorised representative
Beckman Coulter Ireland Inc.
Last updated
11.07.2026 19:52
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details
Vigil Serology Control Level C

Vigil Serology Control Level C

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent
Manufacturer
Beckman Coulter Inc.
Manufacturer SRN
US-MF-000010288
UDI-DI
D-465440QG
Basic UDI-DI
B-465440QG
Reference
465440
EMDN
W0105080899
EMDN description
CONTROLS - INF. IMMUNOLOGY - OTHER
First on market country
Ireland
Authorised representative
Beckman Coulter Ireland Inc.
Last updated
11.07.2026 19:52
Manufacturer productsAuthorised representative productsAuthorised representative actorsView details